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Orange Book product · Brand (NDA)

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PIRFENIDONE

Brand (NDA)NDA 208780TE ABRX LEGACY PHARMA
View PIRFENIDONE familyOpen on FDA Orange Book

At a glance

Jan 11, 2017

Approved

Brand (NDA)

Application

AB

TE code

43

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 11, 2017

    9 yr 7 mo ago

  2. Today

  3. Patent 7767700 expires

    Listed method-of-use patent (U-2080) expiration.

    Dec 18, 2027

    in 1 yr 6 mo

  4. Patent 8420674 expires

    Listed method-of-use patent (U-2079) expiration.

    Dec 18, 2027

    in 1 yr 6 mo

  5. Patent 8383150 expires

    Listed drug product patent expiration.

    May 10, 2028

    in 1 yr 11 mo

  6. Patent 7566729 expires

    Listed method-of-use patent (U-2078) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  7. Patent 7566729 expires

    Listed method-of-use patent (U-2077) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  8. Patent 7635707 expires

    Listed method-of-use patent (U-2083) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  9. Patent 7635707 expires

    Listed method-of-use patent (U-2074) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  10. Patent 7635707 expires

    Listed method-of-use patent (U-2072) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  11. Patent 7635707 expires

    Listed method-of-use patent (U-2075) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  12. Patent 7635707 expires

    Listed method-of-use patent (U-2076) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  13. Patent 7635707 expires

    Listed method-of-use patent (U-2073) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  14. Patent 8592462 expires

    Listed method-of-use patent (U-2060) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  15. Patent 8592462 expires

    Listed method-of-use patent (U-2063) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  16. Patent 8592462 expires

    Listed method-of-use patent (U-2056) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  17. Patent 8592462 expires

    Listed method-of-use patent (U-2058) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  18. Patent 8592462 expires

    Listed method-of-use patent (U-2057) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  19. Patent 8592462 expires

    Listed method-of-use patent (U-2059) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  20. Patent 8592462 expires

    Listed method-of-use patent (U-2061) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  21. Patent 8592462 expires

    Listed method-of-use patent (U-2055) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  22. Patent 8592462 expires

    Listed method-of-use patent (U-2062) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  23. Patent 8609701 expires

    Listed method-of-use patent (U-2065) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  24. Patent 8609701 expires

    Listed method-of-use patent (U-2069) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  25. Patent 8609701 expires

    Listed method-of-use patent (U-2066) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  26. Patent 8609701 expires

    Listed method-of-use patent (U-2067) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  27. Patent 8609701 expires

    Listed method-of-use patent (U-2068) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  28. Patent 8609701 expires

    Listed method-of-use patent (U-2070) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  29. Patent 8609701 expires

    Listed method-of-use patent (U-2064) expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  30. Patent 7816383 expires

    Listed method-of-use patent (U-2042) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  31. Patent 7816383 expires

    Listed method-of-use patent (U-2050) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  32. Patent 7910610 expires

    Listed method-of-use patent (U-2049) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  33. Patent 7910610 expires

    Listed method-of-use patent (U-2048) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  34. Patent 8013002 expires

    Listed method-of-use patent (U-2047) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  35. Patent 8013002 expires

    Listed method-of-use patent (U-2082) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  36. Patent 8084475 expires

    Listed method-of-use patent (U-2052) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  37. Patent 8084475 expires

    Listed method-of-use patent (U-2054) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  38. Patent 8318780 expires

    Listed method-of-use patent (U-2046) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  39. Patent 8318780 expires

    Listed method-of-use patent (U-2081) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  40. Patent 8648098 expires

    Listed method-of-use patent (U-2051) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  41. Patent 8648098 expires

    Listed method-of-use patent (U-2052) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  42. Patent 8754109 expires

    Listed method-of-use patent (U-2053) expiration.

    Jan 08, 2030

    in 3 yr 7 mo

  43. Patent 8778947 expires

    Listed method-of-use patent (U-2044) expiration.

    Aug 30, 2033

    in 7 yr 4 mo

  44. Patent 8778947 expires

    Listed method-of-use patent (U-2045) expiration.

    Aug 30, 2033

    in 7 yr 4 mo

  45. Patent 10188637 expires

    Listed drug product patent expiration.

    Mar 28, 2037

    in 10 yr 11 mo

Pharmaceutical detail

Active ingredient

PIRFENIDONE

Strength

267MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 208780

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (43)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7767700Dec 18, 2027in 1 yr 6 mo
U-2080
8420674Dec 18, 2027in 1 yr 6 mo
U-2079
8383150May 10, 2028in 1 yr 11 mo
ProductU-2361
7566729Apr 22, 2029in 2 yr 11 mo
U-2078
7566729Apr 22, 2029in 2 yr 11 mo
U-2077
7635707Apr 22, 2029in 2 yr 11 mo
U-2083
7635707Apr 22, 2029in 2 yr 11 mo
U-2074
7635707Apr 22, 2029in 2 yr 11 mo
U-2072
7635707Apr 22, 2029in 2 yr 11 mo
U-2075
7635707Apr 22, 2029in 2 yr 11 mo
U-2076
7635707Apr 22, 2029in 2 yr 11 mo
U-2073
8592462Apr 22, 2029in 2 yr 11 mo
U-2060
8592462Apr 22, 2029in 2 yr 11 mo
U-2063
8592462Apr 22, 2029in 2 yr 11 mo
U-2056
8592462Apr 22, 2029in 2 yr 11 mo
U-2058
8592462Apr 22, 2029in 2 yr 11 mo
U-2057
8592462Apr 22, 2029in 2 yr 11 mo
U-2059
8592462Apr 22, 2029in 2 yr 11 mo
U-2061
8592462Apr 22, 2029in 2 yr 11 mo
U-2055
8592462Apr 22, 2029in 2 yr 11 mo
U-2062
8609701Apr 22, 2029in 2 yr 11 mo
U-2065
8609701Apr 22, 2029in 2 yr 11 mo
U-2069
8609701Apr 22, 2029in 2 yr 11 mo
U-2066
8609701Apr 22, 2029in 2 yr 11 mo
U-2067
8609701Apr 22, 2029in 2 yr 11 mo
U-2068
8609701Apr 22, 2029in 2 yr 11 mo
U-2070
8609701Apr 22, 2029in 2 yr 11 mo
U-2064
7816383Jan 08, 2030in 3 yr 7 mo
U-2042
7816383Jan 08, 2030in 3 yr 7 mo
U-2050
7910610Jan 08, 2030in 3 yr 7 mo
U-2049
7910610Jan 08, 2030in 3 yr 7 mo
U-2048
8013002Jan 08, 2030in 3 yr 7 mo
U-2047
8013002Jan 08, 2030in 3 yr 7 mo
U-2082
8084475Jan 08, 2030in 3 yr 7 mo
U-2052
8084475Jan 08, 2030in 3 yr 7 mo
U-2054
8318780Jan 08, 2030in 3 yr 7 mo
U-2046
8318780Jan 08, 2030in 3 yr 7 mo
U-2081
8648098Jan 08, 2030in 3 yr 7 mo
U-2051
8648098Jan 08, 2030in 3 yr 7 mo
U-2052
8754109Jan 08, 2030in 3 yr 7 mo
U-2053
8778947Aug 30, 2033in 7 yr 4 mo
U-2044
8778947Aug 30, 2033in 7 yr 4 mo
U-2045
10188637Mar 28, 2037in 10 yr 11 mo
Product
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